A new method for monitoring the sterility of blood donation

Sterility of blood products is a cardinal contributor to patient safety. Bacteriologic controls of stable products comply with strict regulations, but legislation imposes only limited constraints in the case of perishable products, such as packed red cells (RBCs) or fresh-frozen plasma (FFP). Therefore, it is essential to monitor the sterility of aseptic donations from uninfected donors. Such bacteriologic monitoring can now be carried out through a tertiary bag (containing a soybean casein culture medium) connected to the classical double-pack system. This system does not jeopardize the sterility of the whole system, as the connection is tightly stoppered by a membrane. After the blood drawing, this tertiary bag is filled with 5 ml of blood, and separated from the rest of the system. It is then incubated for 3 days at 30° C and for 14 days at 22° C, to test for eventual bacteriologic or fungal contamination. In order to check the feasibility of this technique, we studied 76 blood drawings in the control laboratory of the blood center, and the results confirm the value of this system.